J&J’s Toxicologist Says Metal From Recalled Hip Harmless

By Maurice Possley & David Voreacos – Feb 22, 2013 3:01 PM ET

A Montana man suing Johnson & Johnson (JNJ)’s DePuy unit over his recalled hip implant wasn’t harmed by the chromium and cobalt debris that entered his tissues and bloodstream, a toxicologist told a jury.

Dennis J. Paustenbach testified yesterday on J&J’s behalf at the first of 10,000 lawsuits to go to trial over the ASR hips, which the company recalled in August 2010. In the case, Loren Kransky, 65, claims the hip implant was defectively designed and J&J failed to warn of the risks.

“I believe that the cobalt and chromium from the ASR implant did not cause or worsen Mr. Kransky’s systemic health problems,” Paustenbach told jurors in state court in Los Angeles. Kransky’s chromium levels were “of insignificant health risk, basically of no health risk.”

Kransky, a retired prison guard, testified earlier that he believed the metal debris was poisoning him. He had a metal cup planted in his hip, and a ball placed atop his femur rotated in the cup. J&J’s lawyers claim the elevated levels of metal in Kransky’s body can be traced to conditions including diabetes, high blood pressure and cholesterol, strokes and kidney cancer. They claim he has diseased blood vessels throughout his body.

J&J, the world’s biggest seller of health-care products, recalled the hips in August 2010 after saying at least 12 percent failed. Since then, the rate has climbed, reaching 40 percent in Australia. Analysts say it could cost New Brunswick, New Jersey-based J&J billions of dollars to resolve the cases.

$5 Million

Paustenbach said his firm ChemRisk Inc. has billed DePuy at least $5 million over the past 18 months. He was part of a team of 40 people who spent thousands of hours studying medical literature and found virtually no research on the effects of cobalt prior to the ASR recall.

He said he also found no evidence of an increased cancer risk. He said the presence of cobalt is “not an issue to be concerned about at concentrations observed in patients with implants.”

Jurors were shown a January publication from the Mayo Clinic in Rochester, Minnesota, which said that “elevated chromium and cobalt concentrations may indicate implant wear, but they are not indications of toxicity.”

Anemia Patients

Paustenbach described an examination by his firm of clinical studies from the 1950s of anemia patients given varying doses of cobalt. His firm created a formula to convert the dosages to blood level readings.

“In the blood, we found that there were virtually no adverse effects in the people who had levels up to 300 parts per billion,” Paustenbach said. Kransky’s highest cobalt reading was 57 parts per billion.

Paustenbach also described a study he conducted of five men and five women who were given dosages of over-the-counter cobalt over 30 days. They showed no adverse effects, he said, although the men reached blood levels of 32 parts per billion and the women hit 91 parts per billion, he said. The unpublished study has been submitted for peer review, he said.

Paustenbach also said that cobalt stimulates the growth of red blood cells. Kransky was chronically deficient in red blood cells, which was further evidence that the cobalt ions weren’t affecting him, the witness said.

“There is no apparent response” to the cobalt levels, he said.

‘Go-To Guy’

On cross-examination by Kransky attorney Brian Panish, Paustenbach reacted angrily when asked if he had been referred to as the “go-to guy for industry.”

“That’s ridiculous,” Paustenbach said. He then acknowledged he had been described in that manner.

In an attempt to depict Paustenbach as biased in favor of industry, Panish read a list of dozens of multinational corporations for which Paustenbach has conducted chemical research. His work, paid for by the companies, has been used to attempt to undermine concerns about exposure to carcinogens such as asbestos and benzene.

Paustenbach was questioned extensively about his firm’s role in a 1997 article published in the Journal of Occupational and Environmental Medicine under the names of two Chinese scientists. The article reversed an earlier study by one of the scientists that found a significant association between chromium in drinking water and higher rates of cancer in rural China.

In 2006, the journal retracted the 1997 article because it failed to disclose that the paper was written by his company, Paustenbach said. His firm had been retained by companies accused of being responsible for chromium pollution.